Senior Regulatory Affairs Associate – Global Labeling Operations

🔥 4 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to communicate planned artwork changes and implementation timelines • Record regulatory assessments and link the Change Management System to the Regulatory Tracking System • Support development and maintenance of regulatory-compliant labeling documents throughout the product lifecycle, including CDS, Global Patient Leaflet, Target Label Profile, EUPI, and USPI • Distribute and track CDS updates in the Electronic Document Management System and regulatory tracking systems • Track implementation of labeling updates across regions and countries • Support Regional and Local Regulatory Leads with Health Authority queries and country-specific labeling differences • Maintain version control and labeling compliance in company systems • Create, maintain, and update regulatory labeling procedures and SOPs • Provide training to internal stakeholders and new joiners on labeling process requirements • Maintain current knowledge of global labeling regulations and governance standards

🎯 Requirements

• 3+ years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations supporting innovative medicines • Direct experience with products developed through the full drug development and registration lifecycle in an innovator company environment • Knowledge and understanding of applicable global regulations, pharmacology, medicine, pharmacovigilance, and drug development • Proven experience with document management systems, regulatory tracking systems, and change management platforms • Strong communication, organization, and problem-solving skills • Demonstrated understanding of labeling governance and compliance • Expertise in regulatory labeling operations, document management systems, and change management processes • Experience working in pharmaceutical or biotechnology regulatory environments with understanding of global labeling requirements • Bachelor's degree in a scientific or medically related discipline (preferred) • Experience with Structured Product Labeling (SPL) and FDA submission processes (preferred) • Familiarity with Electronic Document Management Systems (EDMS) and regulatory tracking platforms (preferred) • Knowledge of ICH-GCP and international regulatory requirements across multiple regions (preferred)

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Additional benefit offerings in accordance with applicable plans • Some roles may be eligible for additional incentives, bonuses, or other compensation programs